Protective Variable Ventilation for Open Abdominal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Variable ventilation has been shown to improve lung function and reduce lung damage as well as inflammation in different models of the acute respiratory distress syndrome. Also, variable ventilation is able to recruit lungs. The present study will investigate whether variable as compared to non-variable ventilation improves post-operative lung function and reduces systemic inflammation in patients submitted to open abdominal surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)

NCT01282996

Protective Lung Ventilation Using: Low Tidal Volume (6-8 mL/kg Predicted Body Weight) PEEP of 6-8 cmH2O +1 more

COMPLETED PHASE4

Influence of Tidal Volume on Postoperative Pulmonary Function

NCT00795964

Pulmonary Function

COMPLETED NA

Individualized Perioperative Open Lung Ventilatory Strategy

NCT02158923

Moderated-high Risk of Postoperative Pulmonary Complication Abdominal Surgery Expected More Than Two Hours

COMPLETED NA

Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient

NCT00538161

Acute Respiratory Distress Syndrome

COMPLETED NA

Pressure Controlled Ventilation Versus Volume Controlled Ventilation in Upper Abdominal Surgery

NCT05690867

Ventilator Lung

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Development of Pulmonary Dysfunction Following Open Abdominal Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Variable Ventilation

Variable tidal volumes with mean at 8 mL/kg of predicted body weight

Group Type ACTIVE_COMPARATOR

Variable Ventilation

Intervention Type OTHER

Non-variable Ventilation

Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Variable Ventilation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* elective open abdominal surgery
* ASA classification 2-3
* age between 18 und 85 yrs
* expected duration of surgery \> 3 h
* expected extubation in the operation room
* written informed consent

Exclusion Criteria

* chronic lung disease (except to COPD stadium I and II, and asthma)
* Body Mass Index (BMI) \> 40
* allergy to one of the drugs to be used for general anesthesia
* participation in another interventional trial within 4 weeks before enrollment
* addiction or any other disease that may interfere with the capacity of giving informed consent
* pregnant or breastfeeding women
* women in reproductive age, except to those who fulfill one of the following:

* post-menopause (12 months natural amenorrhoea, or 6 months amenorrhoea and serum FSH \> 40 mlU/ml
* post-operative (6 weeks after two-sided ovariectomy)
* routine and correct use of anticonceptional methods with failure rate \< 1 % per year
* sexually not active
* vasectomy of the partner
* indication of low compliance with the protocol
* contraindication for MRI examination

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No